Device recall
Z-1403-2025: Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem…
FDA device recall · Class II · ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
Key facts
| Recall number (Z-number) | Z-1403-2025 |
|---|---|
| Recall event | 96398 |
| Product | Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627 |
| Product code | MBF |
| Recalling firm | ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K193038 |
| FEI number | 3012319330 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database